Extended Specialized Assertive Intervention for First Episode Psychosis

Schizophrenia Clinical Trial

— OPUSII  

Official title:

A Randomized Clinical Trial of the Effect of Five-years Versus Two-years Specialized Assertive Intervention for First Episode Psychosis - the OPUS II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00914238
• Other study ID #: Danish OPUS II trial
• Status: Completed
• Phase: N/A
• First received: May 28, 2009
• Last updated: October 24, 2016
• Start date: July 2009
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ministry of HealthDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

In a randomized clinical trial, the researchers want to investigate if the positive short-term outcomes (first 1-2 years), achieved with specialized assertive intervention programme (OPUS), can be maintained for five years if the specialized treatment is sustained over the first five years in comparison to only two years of specialized treatment followed by three years of standard treatment.

Description:

The Danish OPUS I trial succeeded in randomizing 547 patients with first-episode psychosis to a two-year specialized intensive treatment program (OPUS) or standard treatment. The results clearly favored OPUS treatment, and psychotic and negative symptoms, substance abuse, adherence to treatment, use of anti-psychotic medication, user satisfaction, and use of bed days were better in OPUS compared to standard treatment. However, the five-year follow-up, three years after patients from OPUS were transferred to standard treatment, showed that the positive clinical effects were not sustained, when the intensive treatment was terminated, except from OPUS-patients being less likely to stay in institutions than patients who received standard care.

Objective: The aim in OPUS II trial is to compare the effect of five-years versus two-years specialized assertive intervention program (OPUS-treatment) for first episode psychosis on clinical symptoms, substance abuse, institutionalization, and labor market affiliation.

Hypothesis: It is possible to maintain the positive results of the intensive two-year intervention in another three years for those who keep receiving the specialized assertive intervention program.

Design: Open label randomized clinical trial. Setting: Psychiatric Center Bispebjerg and Center for Psychiatric Research Aarhus, Denmark.Participants: 400 patients with first episode of schizophrenia spectrum disorder received treatment in one of the six OPUS - teams for 1½ years.

Intervention: Another 3½ years OPUS-treatment versus ½ year OPUS-treatment and thereafter referral to standard treatment. The extended OPUS treatment consist modified assertive case management, rational pharmacotherapy, family psycho-educational intervention, group interventions to aid with recovery, social skills training, cognitive behavior therapy when indicated, and crisis intervention. OPUS-treatment is tailored to meet the individual patient's needs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 37 Years

Eligibility

Inclusion Criteria:

• patients aged 18 - 37 years

• first episode psychosis in schizophrenia spectrum

• treated for 1½ year in the five OPUS teams in the Capital Region and the OPUS teams in Region Midt

• patients who will give signed informed consent to participate in the trial

Exclusion Criteria:

• patients who are not treated in one of the OPUS team in the Capital Region and Region Midt

• patients who don't give signed informed consent to participate in the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• First Episode Psychosis of Schizophrenia and Schizotypal Disorder
• Mental Disorders
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizotypal Personality Disorder

Intervention

Behavioral:
• 2 years OPUS treatment
2 years OPUS and transfer to standard treatment.
• OPUS 5 years

Locations

Country	Name	City	State
Denmark	Psychiatric Center Bispebjerg	Copenhagen
Denmark	Psychiatric Centre Bispebjerg	Copenhagen

Sponsors (5)

Lead Sponsor	Collaborator
University of Copenhagen	Aarhus University Hospital, Medical Research Council, Mental Health Centre Copenhagen, Region Capital Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS)		3 years	Yes
Secondary	Psychotic symptoms		3 years	Yes
Secondary	Simultaneous remission of both psychotic and negative symptoms.		3 years	Yes
Secondary	Substance abuse.		3 years	Yes
Secondary	Suicidal behaviour.		3 years	Yes
Secondary	Use of bed days.		3 years	Yes
Secondary	Independent living.		3 Years	Yes
Secondary	Labour market affiliation.		3 years	Yes
Secondary	User satisfaction.		3 years	Yes
Secondary	Adherence to treatment.		3 years	Yes
Secondary	Compliance with medication		3 years	Yes